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M8 F9000247

by Asa SRL

Ref F9000257

M8 F9000247 is a device classified as Class IIb in the EU and Class II in the US made by Asa SRL, registered in EUDAMED on 6 May 2026 (Basic UDI-DI B-08033765391214) and listed in FDA GUDID since 11 Feb 2019 (UDI-DI 08033765391214), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08033765391214 Basic UDI-DI 08033765391214UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033765391214 UDI-DI Date11 Feb 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08033765391214 registered 6 May 2026 Active
  • FDA GUDID UDI-DI 08033765391214 listed 11 Feb 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033765391214
  2. Registered EUDAMED B-08033765391214

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
M8
Generic name
Musculoskeletal infrared phototherapy unit, non-wearable
Model / reference
F9000257 EUDAMED
F9000247 GUDID
Primary DI / UDI-DI
08033765391214 EUDAMED
08033765391054 GUDID
Basic UDI-DI
B-08033765391214
FDA product code
ILY
EMDN code
Z120615 Therapeutic lasers
GMDN term
Musculoskeletal infrared phototherapy unit, non-wearable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
890.5500
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
F9000257
GUDID
F9000247
Primary DI / UDI-DIEUDAMED
08033765391214
GUDID
08033765391054
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 08033765391214; FDA GUDID lists 08033765391054), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Musculoskeletal infrared phototherapy unit, non-wearable

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Other devices filed under THERAPEUTIC LASERS.

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Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)